Health TrialsbyHealthPanel

IRONCARE: Iron Treatment in Older Patients With Hip Fractures

ConditionsHip FractureAnemiaIronPlacebo - Control
Trial statusNot yet recruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age75+
SponsorUniversity of Aarhus

About this trial

The aim of this study is to investigate the effects of intravenous (IV) iron therapy compared to alternate-day oral iron treatment and no supplementation in older patients with hip fractures. This study will examine the impact of iron treatment on fatigue, functional decline, fear of falling, cognitive impairment, and quality of life, as well as its effects on iron stores and hemoglobin levels, with the overall goal of improving postoperative rehabilitation.

The trial will be conducted on five different hospitals in the Central Region of Denmark (Region Midtjylland).

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Hip fracture (ICD-10 codes: DS720, DS721 and DS722)

Low energy trauma

Age ≥ 75 years

Hemoglobin ≤7.0 mmol/L (11 g/dL) during hospital admission

Disqualifiers

Pathological fracture

Periprosthetic fracture

Inability to understand or speak Danish

Dysphagia and thus inability to swallow study medication

Trial design

Design model

Parallel

Treatments tested in this trial

  • Ferric Derisomaltose

    Drug

    Intravenous Ferric Derisomaltose shortly after surgery and placebo tablets on alternate days for 90 days

  • Oral Iron (Ferrous sulphate)

    Drug

    Oral iron sulfate on alternate days for 90 days and IV placebo once shortly after surgery

  • Placebo IV

    Drug

    100 ml Sodium Chloride (NaCl)

  • Placebo Tablets

    Drug

    Placebo tablets on alternate days for 90 days

Treatment groups

528 Participants
are divided into 3 treatment groups
Group A: IV IronActive comparator 2 interventions
Group B: Oral IronActive comparator 2 interventions
Group C: PlaceboPlacebo comparator 2 interventions

Trial outcomes

Primary outcomes

1

Fatigue

Measured by Multidimensional Fatigue Inventory tool (MFI-20). MFI-20 is a questionnaire of 20 questions answered on a 5-point scale from "yes, that is true" (1 point) to "no, that is not true" (5 points). A higher score indicates greater severity of fatigue.

Time frame
Baseline and days 30 and 90 after discharge
2

Hemoglobin increment

Defined as a change of level of a minimum of 1.24 mmol/L (2 g/dL). The level of hemoglobin will be measured with a venous blood sample

Time frame
Baseline and days 30 and 90 after discharge
3

Safety profile

Measured as the prevalence and severity of adverse events associated with iron treatment

Time frame
Days 15, 30, 45 and 90 after discharge

Secondary outcomes

1

Physical function - NMS

New Mobility score (NMS) is used to assess the participant's mobility. The participant will be asked three questions ranging from "no difficult and no walking aid" (3 points) to "not able to at all" (0 points). The score ranges from 0 - 9 points. A higher score indicates a higher level of independent mobility.

Time frame
Baseline and days 30 and 90 after discharge
2

Physical function - handgrip strength

Handgrip strength is measured by using a dynamometer that measures the pressure made from a hand grip on the dynamometer in kilograms. A higher score indicates higher handgrip strength.

Time frame
Baseline and days 30 and 90 after discharge.
3

Physical function - 30 second sit-to-stand-test

30 second sit-to-stand-test is used as a parameter for strength, muscle power and dynamic balance. The test is performed by placing a chair with the back against a wall. The participant must be seated on the chair with their arms crossed and are then encouraged to fully stand and sit as many times as possible in 30 seconds. If the arms are used to stand, the score will be 0. A low score indicates low physical ability, and a higher score indicates high physical ability.

Time frame
Baseline and days 30 and 90 after discharge.
4

Fear of Falling

Measured by Short Fall Efficiency Scale-International which is a 7 questions questionnaire assessing the fear of falling from 7 points (low concern of falling) to 28 points (high concern of falling).

Time frame
Days 30 and 90 after discharge

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of Aarhus

Lead sponsor

Region MidtJylland Denmark

Collaborator

Viborg Regional Hospital

Collaborator

Gødstrup Hospital

Collaborator

Aarhus University Hospital

Collaborator

Randers Regional Hospital

Collaborator

Regionshospitalet Horsens

Collaborator

Source ClinicalTrials.gov

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